What are the responsibilities and job description for the Quality Assurance Specialist position at Actalent?
Job Title: Manufacturing Compliance Specialist
Job Description
We are seeking a Manufacturing Compliance Specialist to join our team in Redmond. This role involves supporting manufacturing activities through deviation investigation, report composition, CAPA creation and closeout, and communication of compliance strategies to stakeholders.
Responsibilities
- Perform root cause analysis on manufacturing deviations and create deviation reports.
- Maintain facility GMP compliance and assist in ensuring regulatory inspection readiness.
- Collaborate with team members to ensure project progression and represent the Manufacturing department’s interests on multidisciplinary project teams.
- Serve as a liaison between manufacturing, quality, and process development teams.
- Communicate compliance strategy and rationale clearly, both verbally and in writing.
- Lead investigations for manufacturing issues and bring them to resolution with minimal supervision.
- Initiate corrective and preventative actions (CAPA) to prevent recurrence of deviations.
- Work closely with manufacturing operations and QA team to drive CAPAs to timely closure.
- Operate within site quality and asset management systems.
- Support quality system programs such as Deviation, CAPA, and Change Management.
- Review and assist in record closure for Lot Disposition process.
- Update and revise site manufacturing SOPs.
Essential Skills
- Strong knowledge of FDA and EU regulations for APIs and Drug Products.
- Ability to understand and apply GMP regulations related to manufacturing.
- Strong technical writing skills.
- Minimum of 5 years of experience conducting investigations and root cause analysis in a pharmaceutical or FDA/GMP environment.
- Experience using GMP compliance in clinical/commercial manufacturing environments.
Additional Skills & Qualifications
- B.S. in Chemistry, Biochemistry, Biology, or related scientific discipline preferred.
- Experience using quality management software such as MasterControl, Trackwise preferred.
- Experience with asset management software like Blue Mountain preferred.
- Equivalent education and experience may substitute for stated requirements.
Work Environment
The role operates within a pharmaceutical manufacturing environment, adhering to GMP standards. The position requires close collaboration with multiple teams, including quality and process development, to ensure compliance and project success.
Job Type & Location
This is a Contract to Hire position based out of Redmond, WA.
Pay and Benefits
The pay range for this position is $50.00 - $70.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Redmond,WA.
Application Deadline
This position is anticipated to close on Dec 12, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $50 - $70